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By the time Elite submits the ANDA, the timing for an expected response from the FDA would be around the Aug '18 timeframe.
Not one substantive comment was made about these "loopholes". I am eager to hear all about it. Please enlighten me.
Thanks for insight on Teva.
Goofy b/a this morning on Scottrade:
bid: 0.175
ask: 0.1725
really?!
Wow! Let's hope FDA applies a consistent framework to all.
Very interesting. Great to see they received labeling for all 3 routes. Very promising. I do not know much about Vantrela. What is the mechanism of deterrence?
Lasers, these tiny generics aren't even close to being in the same ballpark.
Could all come down to a pricing game. Hoping Nasrat plays this card right. The first ADT price will set tone for entire pipeline. Set too high & get lower sales result. This is a game of strategic finesse. Pricing too high has slaughtered companies that thought their tech deserved it.
That would make perfect sense. Very interesting.
Purdue has ADT for injection & snorting. ELITE would have to beat on price and/or receive oral ADT labeling to be prescribed.
They stated bioequivalency. What else do you need to hear? This is similar to all other PR's announcing BE, so nothing new here.
Read article few days ago that nothing has to be put on clinical trials.gov. It is up to the ethics and transparency policies of each pharma company. Study in article rated transparency of major pharmacy. Some did ok, some very poor regarding transparency to public. Mixed bag here. Very interesting.
Makes me wonder if this is good news released early to soften upcoming challenging news. Common IR strategy, but hopefully is just timing on still waiting to hear back from FDA.
Yes, very interesting on the physical deterrent properties. Do they have any patents here? I didn't think they did. Hmmm...
Well, are we going to repeat the cycle with a new FDA chief? We will know the accuracy of your statement in the next PR.
I don't disagree with you, but I don't think the FDA is having Elite jump through hoops for naught. I think Elite missed something along the way and is now paying the piper. We have no idea what the discussions behind closed doors entail, but we'll be able to put more pieces together soon enough.
We all need to be patient as we are all in the dark regarding next steps. We have no idea on requirements or expected timing.
This is conjecture just like most other comments here, however, the FDA has to act faster than one year after resubmission per their own guidelines. Now if you said 6 months then there would be some truth and reality. We'll know more in 2 weeks time. Could be good news, but probably not based on all the other setbacks that history shows.
I think it is well beyond just a paper shuffle. The FDA would not reject the NDA and wait 6 months to tell Elite about a simple paper shuffling issue. I think there is much more to the issue.
Perhaps I misinterpreted this PR back then, but I thought these were proposals for an additional much larger study or studies that the FDA would require ELTP to execute. That is the news I was waiting on in the next PR to find out both the fiscal and time setback estimates prior to resubmission.
Funny, but not applicable to Elite's outstanding share count.
Some dilution? Stock has been diluted to smithereens.
And what if Pfizer doesn't take their product to market? Plan B doesn't look nearly as appealing for shareholders.
Yes, that is not the same as buying stock. This was in the agreement from years back that cannot be changed. If it was, what kind of signal would that give to the market?
And when was the last time an insider bought shares?
I agree. Unless I am misinterpreting, but how can the FDA permit market exclusivity? These are 2 different companies, separate products, etc? This prevents free market & competition. I have some thoughts, but in the end not entirely sure why the FDA would allow this.
To think Elite is done paying lawyers regarding any potential litigitation is pure foolishness. Just because they have done some prep work doesn't mean they are done or even remotely close. I have seen the costs of small, medium and large cases. This isn't even remotely close to being done being paid if litigation is pursued. Not even close.
The litigation comes at a high price for a cash strapped company such as Elite. Upon SequestOx approval we do get the $7.5M from Epic, however would be sad to see it used towards litigation. Let's just hope it only gets dragged out months instead of years.
I do recall the insights you have shared regarding the hot melt extrusion process and the limitations. While the FDA knows this already I don't see how they could have approved Troxyca unless the stability issues were resolved. It is exactly why Embeda was initially pulled. They wouldn't want to go through the same embarrassment and allow any attempt to tarnish their reputation.
I am the same way on odd # shares. Ha! Last I bought was back at 0.135 a month or so ago. My order this morning is close to complete.
Decided to buy a little more on drop, but not nearly as much as I wanted. We'll see if rest executes.
I do find it very bizarre that Troxyca has not launched yet.
Thanks for your post from earlier today. Very enlightening regarding the solution vs tablet comparability.
No remember we don't get full rev. We get margin on mfg & % split on rev that has not yet been divulged.
You are exactly right. It is this confusion that I feel doesn't pave a solid path for oral labeling both by a 3rd party panel or internally at the FDA. I could be completely wrong, but I think it easily leaves the door open for the FDA to deny labeling here.
Where have you seen that? Please explain why on Earth companies are trying to refine tech to defeat overdose by swallowing via ADT?
Odds of approval may be higher now (once we know more about next requirements). I also think we have a good chance of getting ADT labeling for snort & injection. I honestly don't even think we have the remotest chance for oral labeling. We can avoid chewing, but not simply swallowing.
I think the perfect solution the FDA is looking for will have a combination of physical & chemical ADT characteristics to get around all the nuances. I could be wrong, but to get a high from Elite's SequestOx, one only needs to swallow more pills. No need to crush, snort, inject. It is even simpler - just take with water.
Pricing of orphan drugs was attacked by both media and Congress in '16. High pricing has killed some drugs in the past. Hoping Nasrat plays this critical card right. One can demand a premium for unique tech, but the company cannot let greed dictate pricing.
Very well thought out & worded. Thank you for bringing the board back to earth. This article has been misinterpreted so much that it is become easy fodder for the naysayers. I look forward to hearing of your other thoughts regarding "the cake". Thanks for the post.
I would agree. If insiders didn't sell at 0.97 (where there was minuscule volume anyway) they certainly aren't selling at $1.00. The ball is in Elite's court. The potential exists to go much higher, but the real & big question is whether this management is going to deliver - a single, double, homerun or grand slam. That has yet to be determined. They've made some fumbles and they acknowledge that. I like the way Nasrat thinks, but not sure we have his full undivided attention with his Mikah side business.